Suspension of Medicines containing Sibutramine
21 January 2010
The Irish Medicines Board (IMB) has today announced, with immediate effect, the suspension of all authorisations in Ireland for medicines containing sibutramine. Currently marketed as Reductil in Ireland, sibutramine is a prescription medicine used to assist weight loss in the treatment of obesity in adult patients or overweight patients with other risk factors such as type-2 diabetes or dyslipidaemia (abnormal levels of fat in the blood).
This suspension is based on a recommendation issued earlier today by the European Medicines Agency. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the risks of these medicines are greater than their benefits and that the marketing authorisations should be suspended across the European Union (EU).
The decision to recommend a suspension of these products follows a pan European review and assessment of data from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial which showed an increased risk of serious cardiovascular events, such as heart attack or stroke, in patients with cardiovascular disease treated with this medicine. The risk is also considered to be applicable to patients without a diagnosis of cardiovascular disease as obesity is a risk factor for cardiovascular disease. In addition, when all available study data were considered, it was noted that the weight loss achieved with sibutramine treatment is modest in comparison with that obtained with placebo.
Please note the following advice which has been issued by the Irish Medicines Board in relation to the suspension of all authorisations for medicines containing sibutramine:
Advice to patients/consumers:
• Stop taking the medicine.
• Return to your doctor when convenient for a review of your condition and further advice.
Advice to Doctors:
• Do not issue any new prescriptions for sibutramine containing medicines and review the treatment of patients currently taking these medicines.
Advice to Pharmacists:
• Do not continue to dispense any sibutramine-containing medicines and quarantine all existing stocks.
• If patients decide to return unused or partially used packs to you, please accept this stock back from patients and place it in quarantine. See IMB Recall Notice for further information.
The IMB is working to inform all patients and healthcare professionals of this issue and has instructed the relevant companies to recall their products from all pharmacies, hospitals and wholesalers immediately.
Download IMB Press Release
Further information, including a Questions and Answers document, is available from the EMA Website.
Patients and healthcare professionals who have any queries can contact the IMB on 01-6764971.
Siobhan Molloy / Angie Grant (Weber Shandwick)
Tel: (01) 676 01 68 or
086 817 5066 / 086 377 2791